TinnitusNCT01187251
Incidence of Tinnitus Amongst Teenagers and Young Adults mp3 Users
An observational study of Tinnitus, run by Faculdade de Medicina de Valenca at 2 sites in Brazil.
Trial summary
The aim of this study is to compare the incidence of tinnitus between mp3 users and non-users, aged between 15 and 30 years old. 100 patients will be recruited in Valença secondary schools. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- How many people
- 100 participants
- Where
- 2 sitesBrazil
- Study dates
- Aug 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: teenagers and young adults (15 to 30 years old)
Who may be able to join
- 15 to 30 years old
- A-n tympanogram
Who cannot join
- muscular tinnitus
- vascular tinnitus
- somatosensorial tinnitus
- concomitant TMJ disorders
- external and middle ear diseases
- professional or recreative exposure to other noise sources other than mp3 players
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
caculdade de Medicina de Valença
Valença, Rio de Janeiro, 27600-000
OTOSUL,Otorrinolaringologia Sul-Fluminense
Volta Redonda, Rio de Janeiro, 27255-650
About this study
The aim of this study is to compare the incidence of tinnitus between mp3 users and non-users, aged between 15 and 30 years old. 100 patients will be recruited in Valença secondary schools. High frequency audiometry and otoacoustic emissions will be performed.Tinnitus patients will complete the Tinnitus Handicap Inventory questionnaire.
- Conditions
- Tinnitus
- Keywords
- tinnitus, mp3 players, noise induced hearing loss, high frequencies audiometry, acoustic otoemissions
- Medical subject headings
- Tinnitus, Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - mp3 users | Subjects who have been using mp3 players for at least 1 hour per day for at least 1 year | |
| Group 2 - mp3 non-users | Subjects who does not listen regularly to mp3 music |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina de Valenca
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187251
- Sponsor's protocol ID
- tinnitus and mp3 players
- Status last verified
- Feb 2010
- First submitted
- 23 Aug 2010
- Last updated
- 24 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Tinnitus Amongst Teenagers and Young Adults mp3 Users
- ClinicalTrials.gov ID
- NCT01187251
- Acronym / sponsor ID
- tinnitus and mp3 players
- Conditions
- Tinnitus
- Keywords
- tinnitus, mp3 players, noise induced hearing loss, high frequencies audiometry, acoustic otoemissions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Faculdade de Medicina de ValencaUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the incidence of tinnitus between mp3 users and non-users, aged between 15 and 30 years old. 100 patients will be recruited in Valença secondary schools. High frequency audiometry and otoacoustic emissions will be performed.Tinnitus patients will complete the Tinnitus Handicap Inventory questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - mp3 users | – | –Subjects who have been using mp3 players for at least 1 hour per day for at least 1 year |
| Group 2 - mp3 non-users | – | –Subjects who does not listen regularly to mp3 music |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- teenagers and young adults (15 to 30 years old)
Key inclusion criteria (2 listed)
- 15 to 30 years old
- A-n tympanogram
Key exclusion criteria (6 listed)
- muscular tinnitus
- vascular tinnitus
- somatosensorial tinnitus
- concomitant TMJ disorders
- external and middle ear diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, run by Faculdade de Medicina de Valenca at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2010.